市售Indomethacin外用製劑之品質調查

An Investigation on the Quality of Indomethacin External Preparations inTaiwan

黃昱綺(Yu-Chi Huang) ； 呂理福(L-F. Lu) ； 陳玉盆(Yu-Pen Chen) ； 黃明權(Ming-Chuan Huang)

《藥物食品檢驗局調查研究年報》 21號 (2003/09) Pp. 17-23

https://doi.org/10.6946/ASRNL.200309.0017

摘要

行政院衛生署於八十五年四月公告『解熱鎮痛藥』等十類指示藥品審查基準，該類藥品之查驗登記，採書面審核，毋須送驗，藥品品質的管控則採加強市售藥品抽驗。吲（口乃木）美洒辛(indomethacin)是一種常用、有效的非類固醇抗發炎、鎮痛的藥品，若為單方外用製劑且含量小於1%（含）者，屬指示藥品管理，另由於indomethacin對光不安定，本計畫即為評估台灣地區現階段市售含indomethacin皮膚外用軟膏、乳膏及凝膠製劑之品質狀況。本局於九十一年三月至六月間函請台灣省及台北、高雄市政府衛生局就轄區內藥局（房）、醫院診所、藥廠及代理商協助抽樣，共抽得檢體37件，依據日本藥局方解說書第十四版所載之試驗方法進行鑑別及含量測定，經試驗結果，含量測定不符合規定者3件，不合格率為8%，不合格產品均已函原送驗單位依相關規定處辦。本調查係本局之比較檢驗，曾於九十一年十二月二十四日發布新聞在案。

關鍵字

Indomethacin ； 吲（口乃木）美洒辛 ； 含量測定 ； HPLC ； 高效液相層析

並列摘要

Indomethacin External Preparations are one of the nonsteroidal anti-inflammatory drugs (NSAIDs) used in the symptomatic treatment of patients with pain and osteoarthritis inflammation and ankylosing spondylitis. This survey was conducted to monitor the quality of marketed Indomethacin External Preparations. Thirty-seven samples were sampled from either the Pharmacy, clinics, manufacturers, and Pharmatheutical agencies in Taiwan area from March to June in 2002. All samples were analyzed according to the analytic method of Indomethacin External Preparations described in the J.P. 14(superscript th) edition. The test items performed included identification and assay The results showed that 3 samples failed to meet the assay specification.
In conclusion, the manufacturers should pay more attention to the manufacturing and quality control techniques, and to validate the manufacturing process, the quality control method, and the product stability before conducting commercial batch production. We recommend that the manufactures emphasize on their manufacturing techniques and quality control system to comply with the government regulation.

並列關鍵字

Indomethacin ； HPLC ； Assay